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U.S. Deregulation

Monsanto submitted a petition to the USDA on April 3, 1995 for the deregulation of its Bt corn variety MON 80100. On June 7, 1995 APHIS published a notice in the Federal Register announcing that the Monsanto petition was available for public review and soliciting public comments, due on or before August 7, 1995. The USDA conducted an environmental assessment (EA) under the National Environmental Policy Act (NEPA) and issued a "finding of no significant impact" (FONSI). MON 80100 was deregulated on August 22, 1995.

Upon deregulation, the USDA reported in the Federal Register:

"Monsanto's corn line MON 80100 has been genetically engineered to express a CryCIA(b) insect control protein derived from the common soil bacterium Bacillus thurigiensis subsp. kurstaki (Btk). Btk proteins are effective against certain lepidopteran insects, including European corn borer (ECB), a major corn pest. Results of field tests conducted by Monsanto under permits and notification granted by APHIS and under an experimental use permit obtained from the EPA indicate that plants producing the CryCIA(b) protein were protected throughout the growing season from leaf and stalk feeding damage by ECB. In addition to expressing the CryCIA(b) protein, the plants also express the selectable marker enzyme 5-enolpyruvyishikimate-3-phoshphate synthase (CP4 EPSPS). The cry1A(b) gene and the CP4 EPSPS marker gene were introduced into the subject corn line by a particle acceleration method and their expression is under the control of the enhanced 35S promoter derived from the plant pathogen cauliflower mosaic virus."[1]